Catalog Number

OS351304

Brand Name

Onatec

Version/Model Number

OS351304

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Public Device Record Key

09255413-f194-4af1-961a-1adf67a7432c

Public Version Date

May 05, 2022

Public Version Number

1

DI Record Publish Date

April 27, 2022

Package DI Number

10848782032980

Quantity per Package

12

Contains DI Package

00848782032983

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box